{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T06:19:21Z","timestamp":1790662761560,"version":"4.1.0"},"reference-count":17,"publisher":"Oxford University Press (OUP)","issue":"11","license":[{"start":{"date-parts":[[2021,2,22]],"date-time":"2021-02-22T00:00:00Z","timestamp":1613952000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100007819","name":"Allergan plc","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007819","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,10,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>ATX-101 (deoxycholic acid) significantly reduced submental fat (SMF) severity in two 24-week Phase 3 studies (REFINE-1 and REFINE-2).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>The aim of this study was to evaluate the durability of effect and long-term safety of ATX-101.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>REFINE study patients who maintained \u22651-grade improvement on the Clinician-Reported SMF Rating Scale (CR-1 responders) 12 weeks after their last REFINE treatment were eligible for enrollment in this multicenter, double-blind, nontreatment, long-term, follow-up study (NCT02163902). The primary endpoint was CR-1 response at Years 1, 2, and 3. Patient-reported satisfaction, psychological impact, and adverse events were monitored.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In total, 224 patients (ATX-101, n\u2005=\u2005113; placebo, n\u2005=\u2005111) were enrolled. Maintenance of CR-1 response was significantly better in the ATX-101 group than in the placebo group at Year 1 (86.4% vs 56.8%; P\u2005&amp;lt;\u20050.001), Year 2 (90.6% vs 73.8%; P\u2005=\u20050.014), and Year 3 (82.4% vs 65.0%; P\u2005=\u20050.03). Most (74%) ATX-101\u2012treated patients satisfied at 12 weeks remained satisfied at Year 3. Significant reductions from baseline in psychological impact scores were sustained through Year 3 (P\u2005&amp;lt;\u20050.001). No new treatment-related adverse events were reported.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Improvements in submental contour achieved with ATX-101 are maintained for 3 years in most patients. No new safety signals emerged.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Level of Evidence: 2<\/jats:title>\n                  <jats:p\/>\n               <\/jats:sec>","DOI":"10.1093\/asj\/sjab100","type":"journal-article","created":{"date-parts":[[2021,2,22]],"date-time":"2021-02-22T20:58:36Z","timestamp":1614027516000},"page":"NP1532-NP1539","source":"Crossref","is-referenced-by-count":18,"title":["Improvements in Submental Contour up to 3 Years After ATX-101: Efficacy and Safety Follow-Up of the Phase 3 REFINE Trials"],"prefix":"10.1093","volume":"41","author":[{"given":"Shannon","family":"Humphrey","sequence":"first","affiliation":[{"name":"clinical assistant professor, Department of Dermatology and Skin Science, University of British Columbia, Vancouver, BC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel L","family":"Cohen","sequence":"additional","affiliation":[{"name":"plastic surgeon in private practice in Greenwood Village, CO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashish C","family":"Bhatia","sequence":"additional","affiliation":[{"name":"associate professor, Northwestern University Feinberg School of Medicine, Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence J","family":"Green","sequence":"additional","affiliation":[{"name":"clinical professor, Department of Dermatology, George Washington University School of Medicine, Washington, DC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeremy B","family":"Green","sequence":"additional","affiliation":[{"name":"clinical assistant professor, Department of Dermatology, University of Miami, Miami, FL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beta","family":"Bowen","sequence":"additional","affiliation":[{"name":"the executive director of global development, Allergan Aesthetics, an AbbVie Company, Irvine, CA, 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